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Search / Trial NCT07035106

I-WEAR: Evaluating Wearables and Health Summaries in ICU Survivors

Launched by LUDWIG BOLTZMANN GESELLSCHAFT · Jun 16, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Wearables Health Related Quality Of Life Icu Survivors Digital Health Remote Patient Monitoring System Usability Scale Sf 36 Bi Weekly Health Summary Pilot Study Pics Cardiovascular Disease Diabetes

ClinConnect Summary

This clinical trial is exploring how wearable devices—like smartwatches, blood pressure monitors, and smart scales—can help people recover after a stay in the intensive care unit (ICU). Many patients who leave the ICU face ongoing challenges with their physical health, mental well-being, and thinking skills, a group of problems known as Post-Intensive Care Syndrome (PICS). The study aims to see if these wearable devices, along with regular digital health updates and optional lifestyle advice, can support recovery and improve quality of life during the months after leaving the ICU.

People who may join the study are adults aged 18 to 65 who spent at least two days in the ICU within the last two years and have diabetes, heart failure, or coronary artery disease. Participants will need to have internet access and a smartphone to use the wearable devices. Those who join will be randomly placed into one of three groups: receiving usual follow-up care, using wearable devices alone, or using wearables plus getting health reports every two weeks and optional coaching on lifestyle changes. The study will last about six months and will look at how well the devices work in real life, how easy they are to use, and how they affect recovery. This research could help shape future care for people recovering from serious illnesses in the ICU.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 18-65 years at the time of ICU admission
  • ICU stay of at least 48 hours
  • ICU discharge within the last 2 years
  • Comorbidity of diabetes mellitus and/or chronic heart failure/coronary artery disease
  • Written informed consent
  • Access to a home internet connection and smartphone with internet and Bluetooth
  • Exclusion Criteria:
  • Presence of a legal guardian
  • No smartphone or internet access
  • No cardiovascular disease/event and/or diabetes
  • Implanted pacemaker or defibrillator
  • Allergies to materials in the wearable devices
  • Transfer from an ICU outside the Medical University of Vienna
  • Homelessness
  • Residence outside of Austria

About Ludwig Boltzmann Gesellschaft

The Ludwig Boltzmann Gesellschaft (LBG) is a prominent research organization dedicated to advancing health sciences through innovative clinical trials and translational research. Based in Austria, LBG fosters interdisciplinary collaboration among researchers, clinicians, and industry partners to address pressing medical challenges and improve patient outcomes. With a strong emphasis on scientific excellence and ethical standards, LBG supports a diverse portfolio of clinical trials that span various therapeutic areas, leveraging cutting-edge methodologies and technologies to drive discoveries from the laboratory to clinical practice. Through its commitment to enhancing healthcare, the Ludwig Boltzmann Gesellschaft plays a vital role in shaping the future of medicine and promoting public health initiatives.

Locations

Patients applied

0 patients applied

Trial Officials

Harald Willschke, Ao. Univ. Prof. Dr.

Study Director

Medical University of Vienna / Ludwig Boltzmann Institute for Digital Health and Patient Safety

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported